InfertileNCT01533350
Receptivity Assessment of Homogeneous Endometrium in Late Follicle Phase
An observational study of Infertile, run by Shen-Zhen City Maternity and Child Healthcare Hospital at 1 site in China.
Trial summary
Twenty eight infertile women undergoing ultrasonographic endometrial assessment in the late follicle phase, fourteen of them with homogeneous echo endometrium (group 1) and other fourteen with trilaminar endometrium (group 2), were included from our Department. Read more about this study
- Who is it for?
- Ages 26 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertile
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The mean age of the women were 31.9±3.7 years ( range, 26-39 years). The mean body mass index was 20.96±2.46 kg/m2 (range, 17.58-26.04 kg/m2).With a regular menstral cycle (25-35days) and 2-11 years infertile history, all subjects had signed the proper consent forms.
Who may be able to join
- infertile
- ≤ 40 years of age
- regular menstrual cycles (25-35 days)
- without use of an intrauterine devices or oral contraceptive at least 3 months before the study.
Who cannot join
- polycystic ovarian syndrome (PCOS)
- endometriosis
- premature ovarian failure (POF)
- an abortion within 1 year
- pelvic inflammatory disease history
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Reproductive Healthcare, Shen-Zhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong, 518000
About this study
Official title: Receptivity Assessment of Homogeneous Endometrium in Late Follicle Phase of Infertile Women With Natural Cycles
Twenty eight infertile women undergoing ultrasonographic endometrial assessment in the late follicle phase, fourteen of them with homogeneous echo endometrium (group 1) and other fourteen with trilaminar endometrium (group 2), were included from our Department. The endometrial tissues were collected and Four biomarkers for endometrial receptivity and ultrastructure were assessed before and 6-7 days after ovulation.
Read the detailed description
Subjects Twenty eight apparently healthy women, fourteen of them with a ultrasonographic homogeneous echo(group 1) and other fourteen with a " triple-line"(group 2) endometrium in the late follicle phase, were involved in our Department for the study between September 2010 and November 2011. The included criteria for both groups of women were ≤40 years of age, with a regular menstrual cycles (25-35 days), without use of an intrauterine devices or oral contraceptive at least 3 months before the study. Exclusion criteria were women with polycystic ovarian syndrome (PCOS), endometriosis, premature ovarian failure (POF) and an abortion within 1 year or a history of pelvic inflammatory disease. The mean age of the women were 31.9±3.7 years ( range, 26-39 years). The mean body mass index was 20.96±2.46 kg/m2 (range, 17.58-26.04 kg/m2).With a regular menstrual cycle (25-35days) and 2-11 years infertile history, all subjects had signed the proper consent forms. The study was approved by our Institutional Ethics committee.
Ovulation monitoring The women were followed for one cycle by obtaining blood samples and urine samples. The ovulation was monitored with vaginal ultrasonography (aloka-1000, UST-985, 5 MHz transvaginal probe, aloka Co. Ltd, Tokyo, Japan). The thickness of two endometrial layers was measured. The endometrial pattern was assessed according to the classification proposed by Gonen and Casper as follows: an endometrium that was entirely homogeneously hyperechoic without a central echogenic line was considered as a homogeneous echo pattern and triple-line pattern consisted of a central hyperechoic line surrounded by two hypoechoic layers. The growth of follicles, ovulation and the development of corpus luteum were monitored by using two-plane scans. Participants identified the day of the LH surge by testing the morning urine (David ovulation test, Rubio Biotech Co. Ltd., Shantou, China). The day of the LH surge was determined in urine samples when LH surge reached its highest value on which the blood samples were collected as well. The cycle day referred to the first day of menstrual bleeding. Women who have normal ovulatory cycles with intervals of 25-35 days are expected to ovulate on day 11 at the earliest and day 21at the latest. The peripheral blood samples were obtained by vein puncture on the day of the LH surge and 6-7 days after ovulation. Blood was separated by centrifugation within 1 hour, and the serum was stored at -20℃ until the concentrations of LH, FSH, estradiol (E2) and progesterone were assayed.
Endometrial biopsy Two endometrial biopsies were performed during a single menstrual cycle in each subject. The early biopsy was performed on the pre-ovulatory day (late follicle phase) and the endometrial tissues were collected from the anterior wall of the uterine cavity. Whereas the late biopsy was performed on ovulation day +7 (midluteal phase or implantation widow phase), and the endometrial sample was collected from the posterior wall of the uterine cavity with or without dilatation of the cervix by using an endometrial curette (#4164 prebet, Genetics, pommel, Belgium). Each sample was divided into three pieces and immediately fixed. Samples for scanning electron microscopy for fixed in a solution containing 2.5% (wt/vol) glutaraldehyde, 0.5% paraformaldehyde, 0.1 mol/L of sucrose, 0.1 mol/L of sodiumcacodylate, and 3 mmol/L of calciumchloride (pH, 7.4). Samples for immunohistochemistry were fixed in 4% formalin . Samples for transmission electron microscopy was fixed by 2.5% glutaraldehyde arsenate ;
Scanning electron microscopy Samples were washed twice in a buffer containing 0.15 mol/L of sodiumcacodylate and 3 mmol/L of calcium chloride (PH, 7.4) and once in distilled water. The specimens were dehydrated first in increasing concentrations of ethanol (70%,95%,and 99.5%) and then in acetone; they were dried in a critical-point dryer by using carbon dioxide. The specimens were mounted, coated with platinum, and examined by using a scanning electron microscope ( S-3000N, Hitachi, Tokyo, Japan). The developmental phase of the pinopode were classified. Because the pinopodes on the endometrial surface do not develop at exactly the same time the pinopodes were not evenly distributed over the endometrial surface, thus, in our study, we examined five fields each biopsy sample and analyzed the development and distribution of pinopodes. The morphology evaluation was defined as: no pinopodes,developing pinopodes,fully developed pinopodes and regressing pinopodes. The semi-quantitative evaluation was defined as following:- (0%), + (﹤20%), ++ (20-50%) and +++(>50%).
Immunohistochemistry 56 biopsy samples of 28 patients were used for immunohistochemical analysis. For LIF, integrin αv, VEGF and MMP-9 studies 4 um paraffin-embedded sections were deparaffinized 20 min in acetone at 70℃. Endogenous peroxidase was blocked with 3% H2O2 for 10 min. Antigen retrieval was boiling by heating for 5 min in 0.01 M citrate buffer at pH 6.0,and then the sections were incubated overnight at 4℃ with the specific antibodies which were diluted at 1:50. The antibodies used in this study were polyclonal antibodies (PAB) LIF, integrin αv, VEGF and MMP-9 (BA 1239, BA0957,BA0407 and BA0573, Booster Co Ltd, Wuhan, China). The sections were rinsed in phosphate-buffered saline (PBS), blocked with 10% normal goat serum for 30 min and then incubated with goat anti-rabbit biotinylated immunoglobulins (IgG)(SV0002, Booster Co Ltd, Wuhan, China) at 37℃ for 30 min. For integrin β3 study, the sections were incubated with 3% hydrogen peroxide for 10 min after hot repair of antigen by boiling at 95℃ of 0.01M citrate buffer(pH6.0), then incubated with polyclonal antibodies integrin β3 (sc-6626, santa, USA) diluted at 1:100 overnight at 4℃. Polymer Helper (PV-9003, Zhong-Shang Co Ltd, Beijing, China) was added at room temperature and with a interval of 20 min, Poly Peroxidase-anti-goat IgG (PV-9003, Zhong-Shang Co Ltd, Beijing, China) was added. The slides were then washed in PBS and colored by 3,3-diaminobenzidine in H2O2 (DAB, vitrogen, California, USA). The sections were finally washed in water. In every case a negative control was performed by omission of incubation with the primary specific antibody. The reactivity of each polyclonal antibody with endometrial glands and surface epithelium, stromal cells was assessed. Staining was evaluated semiquantitatively by using a grading system. Staining intensity and the number of stained cells were graded on a scale of 0=no staining, +/- = few stained cells, + = faint staining, ++ = moderate staining, and +++ = strong staining. The formula of H-score=ΣPi(i+1) was used to calculation. One observer who was blinded to identify of the slides performed all the assessments. After completion of the study, the same observer reexamined the slides to ensure reproducibility of the semiquantitative assessment.
Transmission electron microscopy Specimens for transmission electron microscopy were fixed in 2.5% glutaraldehyde in PBS (pH 7.4) and post-fixed in 1% osmium tetroxide. After dehydration in a graded ethanol series, specimens were placed in propylene oxide and embedded in Epon, stained with uranyl acetate and lead citrate and examined in transmission electron microscope .
Statistical Analysis The Statistics Package for Social Science (SPSS 13.0; SPSS Inc., Chicago, IL) was used for statistical analyses. The mean±S.D was evaluated using analysis of student's t-test ,ranked data was analyzed with the Rank Sum Test (Mann-Whitney test) and qualitative data was analyzed with chi-square test . Statistical significance was set at P<0.05(two tailed).
- Conditions
- Infertile
- Keywords
- Ultrasonography, late follicle phase, homogeneous endometrium, receptivity, biochemical factor, ultrastructure, endometrial echo pattern
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group1 | women with a ultrasonographic homogeneous echo endometrium in the late follicle phase | |
| group2 | women with a ultrasonographic " triple-line" endometrium in the late follicle phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular endothelial growth factor(VEGF)
The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.
Measured: 2 month
pinopodes
The specimens were mounted, coated with platinum, and examined by using a scanning electron microscope ( S-3000N, Hitachi, Tokyo, Japan). The pinopodes morphology evaluation was defined as: no pinopodes,developing pinopodes,fully developed pinopodes and regressing pinopodes. The semi-quantitative evaluation was defined as following:- (0%), + (<20%), ++ (20-50%) and +++(>50%).
Measured: 2month
Ultrastructure
Ultrastructure was observed by transmission electron microscopy
Measured: 2 month
leukemia inhibitory factor(LIF)
The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.
Measured: 2 months
integrin ɑvβ3
The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.
Measured: 2 months
matrix metalloproteinase-9(MM-9)
The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startSep 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shen-Zhen City Maternity and Child Healthcare Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Jie Zhu, Shen-Zhen City Maternity and Child Healthcare Hospital
- Investigators
- Wen-Jie Zhu, M.D, Study chair, Shenzhen Maternity & Child Healthcare Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533350
- Sponsor's protocol ID
- 201002089
- Status last verified
- Feb 2012
- First submitted
- 3 Feb 2012
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Receptivity Assessment of Homogeneous Endometrium in Late Follicle Phase of Infertile Women With Natural Cycles
- ClinicalTrials.gov ID
- NCT01533350
- Acronym / sponsor ID
- 201002089
- Conditions
- Infertile
- Keywords
- Ultrasonography, late follicle phase, homogeneous endometrium, receptivity, biochemical factor, ultrastructure, endometrial echo pattern
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shen-Zhen City Maternity and Child Healthcare HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty eight infertile women undergoing ultrasonographic endometrial assessment in the late follicle phase, fourteen of them with homogeneous echo endometrium (group 1) and other fourteen with trilaminar endometrium (group 2), were included from our Department. The endometrial tissues were collected and Four biomarkers for endometrial receptivity and ultrastructure were assessed before and 6-7 days after ovulation.
Detailed description
Subjects Twenty eight apparently healthy women, fourteen of them with a ultrasonographic homogeneous echo(group 1) and other fourteen with a " triple-line"(group 2) endometrium in the late follicle phase, were involved in our Department for the study between September 2010 and November 2011. The included criteria for both groups of women were ≤40 years of age, with a regular menstrual cycles (25-35 days), without use of an intrauterine devices or oral contraceptive at least 3 months before the study. Exclusion criteria were women with polycystic ovarian syndrome (PCOS), endometriosis, premature ovarian failure (POF) and an abortion within 1 year or a history of pelvic inflammatory disease. The mean age of the women were 31.9±3.7 years ( range, 26-39 years). The mean body mass index was 20.96±2.46 kg/m2 (range, 17.58-26.04 kg/m2).With a regular menstrual cycle (25-35days) and 2-11 years infertile history, all subjects had signed the proper consent forms. The study was approved by our Institutional Ethics committee.
Ovulation monitoring The women were followed for one cycle by obtaining blood samples and urine samples. The ovulation was monitored with vaginal ultrasonography (aloka-1000, UST-985, 5 MHz transvaginal probe, aloka Co. Ltd, Tokyo, Japan). The thickness of two endometrial layers was measured. The endometrial pattern was assessed according to the classification proposed by Gonen and Casper as follows: an endometrium that was entirely homogeneously hyperechoic without a central echogenic line was considered as a homogeneous echo pattern and triple-line pattern consisted of a central hyperechoic line surrounded by two hypoechoic layers. The growth of follicles, ovulation and the development of corpus luteum were monitored by using two-plane scans. Participants identified the day of the LH surge by testing the morning urine (David ovulation test, Rubio Biotech Co. Ltd., Shantou, China). The day of the LH surge was determined in urine samples when LH surge reached its highest value on which the blood samples were collected as well. The cycle day referred to the first day of menstrual bleeding. Women who have normal ovulatory cycles with intervals of 25-35 days are expected to ovulate on day 11 at the earliest and day 21at the latest. The peripheral blood samples were obtained by vein puncture on the day of the LH surge and 6-7 days after ovulation. Blood was separated by centrifugation within 1 hour, and the serum was stored at -20℃ until the concentrations of LH, FSH, estradiol (E2) and progesterone were assayed.
Endometrial biopsy Two endometrial biopsies were performed during a single menstrual cycle in each subject. The early biopsy was performed on the pre-ovulatory day (late follicle phase) and the endometrial tissues were collected from the anterior wall of the uterine cavity. Whereas the late biopsy was performed on ovulation day +7 (midluteal phase or implantation widow phase), and the endometrial sample was collected from the posterior wall of the uterine cavity with or without dilatation of the cervix by using an endometrial curette (#4164 prebet, Genetics, pommel, Belgium). Each sample was divided into three pieces and immediately fixed. Samples for scanning electron microscopy for fixed in a solution containing 2.5% (wt/vol) glutaraldehyde, 0.5% paraformaldehyde, 0.1 mol/L of sucrose, 0.1 mol/L of sodiumcacodylate, and 3 mmol/L of calciumchloride (pH, 7.4). Samples for immunohistochemistry were fixed in 4% formalin . Samples for transmission electron microscopy was fixed by 2.5% glutaraldehyde arsenate ;
Scanning electron microscopy Samples were washed twice in a buffer containing 0.15 mol/L of sodiumcacodylate and 3 mmol/L of calcium chloride (PH, 7.4) and once in distilled water. The specimens were dehydrated first in increasing concentrations of ethanol (70%,95%,and 99.5%) and then in acetone; they were dried in a critical-point dryer by using carbon dioxide. The specimens were mounted, coated with platinum, and examined by using a scanning electron microscope ( S-3000N, Hitachi, Tokyo, Japan). The developmental phase of the pinopode were classified. Because the pinopodes on the endometrial surface do not develop at exactly the same time the pinopodes were not evenly distributed over the endometrial surface, thus, in our study, we examined five fields each biopsy sample and analyzed the development and distribution of pinopodes. The morphology evaluation was defined as: no pinopodes,developing pinopodes,fully developed pinopodes and regressing pinopodes. The semi-quantitative evaluation was defined as following:- (0%), + (﹤20%), ++ (20-50%) and +++(>50%).
Immunohistochemistry 56 biopsy samples of 28 patients were used for immunohistochemical analysis. For LIF, integrin αv, VEGF and MMP-9 studies 4 um paraffin-embedded sections were deparaffinized 20 min in acetone at 70℃. Endogenous peroxidase was blocked with 3% H2O2 for 10 min. Antigen retrieval was boiling by heating for 5 min in 0.01 M citrate buffer at pH 6.0,and then the sections were incubated overnight at 4℃ with the specific antibodies which were diluted at 1:50. The antibodies used in this study were polyclonal antibodies (PAB) LIF, integrin αv, VEGF and MMP-9 (BA 1239, BA0957,BA0407 and BA0573, Booster Co Ltd, Wuhan, China). The sections were rinsed in phosphate-buffered saline (PBS), blocked with 10% normal goat serum for 30 min and then incubated with goat anti-rabbit biotinylated immunoglobulins (IgG)(SV0002, Booster Co Ltd, Wuhan, China) at 37℃ for 30 min. For integrin β3 study, the sections were incubated with 3% hydrogen peroxide for 10 min after hot repair of antigen by boiling at 95℃ of 0.01M citrate buffer(pH6.0), then incubated with polyclonal antibodies integrin β3 (sc-6626, santa, USA) diluted at 1:100 overnight at 4℃. Polymer Helper (PV-9003, Zhong-Shang Co Ltd, Beijing, China) was added at room temperature and with a interval of 20 min, Poly Peroxidase-anti-goat IgG (PV-9003, Zhong-Shang Co Ltd, Beijing, China) was added. The slides were then washed in PBS and colored by 3,3-diaminobenzidine in H2O2 (DAB, vitrogen, California, USA). The sections were finally washed in water. In every case a negative control was performed by omission of incubation with the primary specific antibody. The reactivity of each polyclonal antibody with endometrial glands and surface epithelium, stromal cells was assessed. Staining was evaluated semiquantitatively by using a grading system. Staining intensity and the number of stained cells were graded on a scale of 0=no staining, +/- = few stained cells, + = faint staining, ++ = moderate staining, and +++ = strong staining. The formula of H-score=ΣPi(i+1) was used to calculation. One observer who was blinded to identify of the slides performed all the assessments. After completion of the study, the same observer reexamined the slides to ensure reproducibility of the semiquantitative assessment.
Transmission electron microscopy Specimens for transmission electron microscopy were fixed in 2.5% glutaraldehyde in PBS (pH 7.4) and post-fixed in 1% osmium tetroxide. After dehydration in a graded ethanol series, specimens were placed in propylene oxide and embedded in Epon, stained with uranyl acetate and lead citrate and examined in transmission electron microscope .
Statistical Analysis The Statistics Package for Social Science (SPSS 13.0; SPSS Inc., Chicago, IL) was used for statistical analyses. The mean±S.D was evaluated using analysis of student's t-test ,ranked data was analyzed with the Rank Sum Test (Mann-Whitney test) and qualitative data was analyzed with chi-square test . Statistical significance was set at P<0.05(two tailed).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group1 | – | –women with a ultrasonographic homogeneous echo endometrium in the late follicle phase |
| group2 | – | –women with a ultrasonographic " triple-line" endometrium in the late follicle phase |
Who may qualify
- Ages
- 26 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The mean age of the women were 31.9±3.7 years ( range, 26-39 years). The mean body mass index was 20.96±2.46 kg/m2 (range, 17.58-26.04 kg/m2).With a regular menstral cycle (25-35days) and 2-11 years infertile history, all subjects had signed the proper consent forms.
Key inclusion criteria (4 listed)
- infertile
- ≤ 40 years of age
- regular menstrual cycles (25-35 days)
- without use of an intrauterine devices or oral contraceptive at least 3 months before the study.
Key exclusion criteria (5 listed)
- polycystic ovarian syndrome (PCOS)
- endometriosis
- premature ovarian failure (POF)
- an abortion within 1 year
- pelvic inflammatory disease history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vascular endothelial growth factor(VEGF)
Time frame: 2 month
The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.
pinopodes
Time frame: 2month
The specimens were mounted, coated with platinum, and examined by using a scanning electron microscope ( S-3000N, Hitachi, Tokyo, Japan). The pinopodes morphology evaluation was defined as: no pinopodes,developing pinopodes,fully developed pinopodes and regressing pinopodes. The semi-quantitative evaluation was defined as following:- (0%), + (<20%), ++ (20-50%) and +++(>50%).
Ultrastructure
Time frame: 2 month
Ultrastructure was observed by transmission electron microscopy
leukemia inhibitory factor(LIF)
Time frame: 2 months
The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.
integrin ɑvβ3
Time frame: 2 months
The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.
matrix metalloproteinase-9(MM-9)
Time frame: 2 months
The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Jie Zhu, M.D study chair
Shenzhen Maternity & Child Healthcare Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertile, run by Shen-Zhen City Maternity and Child Healthcare Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vascular endothelial growth factor(VEGF) (time frame: 2 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.